Last updated: 10/21/2024 07:00:14

A study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered with a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants

GSK study ID
214099
See study documents
Clinicaltrials.gov ID
NCT05602025
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered with a Safety Syringe Device or an Autoinjector in Healthy Adult Participants
Trial description: This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Maximum observed plasma concentration (Cmax) of depemokimab

Timeframe: Up to Week 26

Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) of depemokimab

Timeframe: Up to Week 26

Secondary outcomes:

Area under the concentration time curve from time zero to time of last observed quantifiable concentration (AUC[0-t]) of depemokimab

Timeframe: Up to week 26

Time to maximum observed plasma concentration (Tmax) of depemokimab

Timeframe: Up to Week 26

Apparent clearance following extravascular administration (CL/F) of depemokimab

Timeframe: Up to Week 26

Apparent volume of distribution following extravascular administration (Vd/F) of depemokimab

Timeframe: Up to week 26

Terminal elimination rate constant (lambda z) of depemokimab

Timeframe: Up to Week 26

Terminal elimination half life (T1/2) of depemokimab

Timeframe: Up to Week 26

Time of last measurable plasma concentrations (Tlast) of depemokimab

Timeframe: Up to week 26

Percentage of AUC(0-inf) due to extrapolation from Tlast to infinity (%AUCex) of depemokimab

Timeframe: Up to Week 26

Number of participants with presence of anti-drug antibody and neutralizing antibody to depemokimab

Timeframe: Pre-dose and Weeks 4, 8, 12, 26 post dose

Interventions:
  • Biological/vaccine: Depemokimab
    • Enrollment:
    140
    Primary completion date:
    2023-23-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    Not applicable
    Collaborators
    PPD Development LP
    Study date(s)
    December 2022 to October 2023
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 Years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
    • Body weight greater than or equal to (>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive).
    • Women who have the potential to become pregnant must use a form of highly-effective contraception.
    • Capable of giving signed informed consent. Exclusion Criteria:
    • History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
    • Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/intolerance.
    • Current evidence or recent history of an infective illness.
    • A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
    • Clinically significant abnormalities.
    • Positive test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at screening.
    • Recent prior or concurrent clinical study experience.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78744
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89113
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32806
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2023-23-10
    Actual study completion date
    2023-23-10

    Plain language summaries

    Summary of results in plain language
    Available language(s): English
    Download document(s)

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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